Uro-V Cystoscope

K171500 · Uroviu Corporation · FAJ · Jan 30, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K171500
• Device Name: Uro-V Cystoscope
• Applicant: Uroviu Corporation
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Jan 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Uro-V cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.

Device Story

Handheld, battery-operated portable cystoscope; consists of reusable handle and sterile, single-use disposable cannula. Cannula tip contains miniature CMOS camera and LED illumination module; includes working channel for fluid infusion. Handle integrates video processor, 3.5-inch LCD display, rechargeable battery, and control buttons for brightness, image capture, and video recording. Used in hospitals and physician offices by clinicians to visualize bladder and urethra. Physician views procedure directly on integrated handle display. Output facilitates real-time endoscopic diagnosis and therapeutic access via working channel. Benefits include portability and elimination of external tower/cables.

Clinical Evidence

Bench testing only. Studies included design verification/validation, packaging/shelf-life, transit, biocompatibility (ISO 10993-1), sterilization validation (ISO 11135-1, ISO 11607), electrical safety/EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18), thermal safety, and optical performance (field of view, direction of view, resolution).

Technological Characteristics

Handheld endoscope; 4.2 mm outer diameter cannula; 2.8 mm working channel; 254 mm working length. CMOS camera; LED illumination. 3.5-inch integrated LCD. Battery-powered. Biocompatible materials per ISO 10993. Cannula sterilized via ethylene oxide (EO). Handle reusable, cleaned/disinfected per AAMI TIR12/TIR30. Firmware-controlled.

Indications for Use

Indicated for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra in patients requiring cystoscopy.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• VISCERA Cystovideoscope Type CYF V, Olympus American, Inc. (K021074)

Submission Summary (Full Text)

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January 30, 2018

UroViu Corporation Thomas Lawson, Ph.D. Vice President, Regulatory Affairs 5337 - 14th Place SE Bellevue, WA 98006

Re: K171500

Trade/Device Name: Uro-V Cystoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ Dated: December 21, 2017 Received: December 22, 2017

Dear Thomas Lawson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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Division Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K171500

Device Name Uro-V Cystoscope

### Indications for Use (Describe)

The Uro-V cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.

Type of Use (*Select one or both, as applicable*):

| <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

#### I. SUBMITER:

UroViu Corporation 5337 14th Place SE Bellevue, WA 98006 Phone: [phone] Fax: [phone]

Contact Person: Thomas Lawson, PhD

> Phone: [phone] eMail: [e-mail]

May 11, 2017 Submission Date:

#### II. DEVICE

Device Name: Uro-V Cystoscope Common Name: Cystoscope Classification Name: Endoscope and Accessories (21 CFR 876.1500) Regulatory Class: II Product Code: FAJ Classification Panel: 78

#### III. PREDICATE DEVICE

VISCERA Cystovideoscope Type CYF V, Olympus American, Inc. K021074

#### DEVICE DESCRIPTION IV.

The UroViu Uro-V cystoscope is a handheld, battery-operated portable cystoscope. It includes a sterile, single-use disposable cannula and a reusable handle. The disposable cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and one channel for infusion of irrigating fluid. The handle is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the disposable cannula. The handle contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or to start/stop a video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.

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#### V. INDICATIONS FOR USE

The Uro-V cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.

#### VI. SUBSTANTIAL EQUIVALENCE

The Uro-V device is substantially equivalent to the VISCERA cystovideoscope Type CYF V manufactured by Olympus America, Inc. (K021074) in terms of indications for use, route the devices are introduced and advanced within the body, capability to view the urethra and bladder, having a working channel to allow instillation of fluids and introduction of endourological tools, and being made from biocompatible materials.

| | Subject device<br>Uro-V cystoscope<br>(this submission) | Predicate device<br>VISCERA Cystovideoscope Type<br>CYF V<br>Olympus America, Inc.<br>(K021074) |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | For endoscopic diagnosis and<br>infusion of fluids within the<br>bladder and urethra. | This instrument has been<br>designed to be used with an<br>Olympus video system center,<br>light source, documentation<br>equipment, display monitor,<br>endo-therapy accessories, and<br>other ancillary equipment for<br>endoscopic diagnosis and<br>treatment within the bladder and<br>urethra. |
| Intended Use | The Uro-V cystoscope has been<br>designed for endoscopic<br>diagnosis and infusion of<br>irrigating fluid within the bladder<br>and urethra. | The cystovideoscope is used for<br>endoscopic diagnosis and<br>treatment within the bladder and<br>urethra. |
| Route of<br>Advancement | Advanced to the bladder via the<br>urethra | Advanced to the bladder via the<br>urethra |
| Site of use | Hospitals and physician offices | Hospitals and physician offices |
| Device Features | | |
| Components | Reusable handle with video<br>screen | Optic component with an<br>insertion tube that has one<br>working channel |
| | Attachable cannula with a<br>working channel along its length<br>and an illumination source and<br>camera at its tip | Additional components necessary<br>for the visualization of the<br>procedure are a light source,<br>video system center, and display<br>monitor, which are provided<br>separately from the<br>cystovideoscope itself |
| Cannula / Insertion<br>Tube Outer Diameter | 4.2 mm | 5.5 mm |
| Working length | 254 mm | 380 mm |
| Working channel<br>internal diameter | 2.8 mm | 2.2 mm |
| Illumination light<br>source | LEDs | Xenon short-arc lamp |
| Image transmission | Image transmitted from a video<br>camera at the tip of the cannula to<br>a video monitor on the handle | Either the physician will view by<br>looking through the cystoscope's<br>eyepiece or by attaching a<br>coupling lens to the eyepiece of<br>the scope and sending that image<br>to a video monitor in the<br>procedure room |
| LCD display size | 3.5 inches (diagonal) on the<br>handle | 26 inches (diagonal) on the<br>system tower |
| Field of View | 140 degrees | 120 degrees |
| Focal Length | 5 to 25 mm | 3 to 50 mm |
| Direction of View<br>from Center Axis | 30 degrees | 0 degrees (forward viewing) |
| Adjust brightness of<br>illumination | Adjust by depressing a button on<br>the handle to change settings | Adjust by changing settings on<br>the ancillary light source<br>equipment |
| Capture still images<br>or video images<br>during the procedure | Capture still images or video<br>during procedure by depressing a<br>camera button on the handle | Capture still images or video<br>during procedure by use of an<br>ancillary video system center<br>equipment |
| Duration of use | < 24 hours | < 24 hours |
| Sterilization | The handle is not provided sterile.<br>The handle is cleaned,<br>disinfected, or sterilized<br>following company instructions.<br>The disposable cannula is<br>provided sterile following<br>exposure to ethylene oxide (EO)<br>and is single use; it is disposed<br>after the procedure following the<br>institution's procedures. | Cystovideoscope is not provided<br>sterile. The device is cleaned,<br>disinfected, or sterilized<br>following company instructions. |
| Frequency of use | Handle is reusable.<br>Cannula is single patient use. | Cystovideoscope is reusable. |
| Tissue contact<br>materials | Compliant with ISO 10993 | Compliant with ISO 10993 |

Table I. Comparison of the Uro-V cystoscope to the predicate device, the Olympus VISCERA Cystovideoscope Type CYF V.

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Any differences between the Uro-V cystoscope and the predicate device do not alter the intended use of the Uro-V cystoscope.

### VII. PERFORMANCE DATA

All necessary performance testing was conducted with bench testing and included:

- Design verification and validation studies; ●
- Packaging and shelf-life studies: ●
- Transit testing;
- Biocompatibility testing;
- Sterilization procedure validation;
- . Software verification and validation;
- Surface and edges evaluation;
- Cannula dimensions (maximum insertion width, minimum instrument ● channel width);
- . Electrical safety, electromagnetic compatibility, and laser safety testing;
- Temperature testing of the surface of the insertion of the device; and ●
- Optical tests ●
- o Field of view accuracy

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- Direction of view accuracy O
- O Optical resolution.

Testing was conducted on the device to verify that it is compliant with biocompatibility requirements for a short duration indwelling device, as specified in ISO 10993 - Part 1. The device was found to meet the compliance requirements for electrical safety as specified in ISO 60601-1 including provisions for EMC safety in ISO 60601-1-2 and IEC 60601-2-18 Medical electrical equipment -- Part 2-18: "Particular requirements for the basic safety and essential performance of endoscopic equipment," including thermal safety. Mechanical characteristics were also tested, with successful results. Due to the cannula being labeled as sterile, the cannula underwent sterilization validation and shelf life testing to confirm the label shelf life complies with the following standards:

- ISO 11135-1 Sterilization of health care products -- Ethylene oxide -Part 1: Requirements for development, validation and routine control of a sterilization process for medical device;
- ISO 11607 Packaging for Terminally Sterilized Medical Devices; ●
- AAMI TIR12:2010 Designing, testing, and labeling ● reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers; and
- AAMI TIR30:2011 - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.

# VIII. CONCLUSION

The Uro-V cystoscope and the VISCERA Cystovideoscope Type CYF V have the same intended use and indications for use and have equivalent technological characteristics. The minor differences between the Uro-V cystoscope and the predicate device do not raise any new issues of safety or effectiveness. The Uro-V cystoscope is substantially equivalent to the identified predicate device.